QA Operations Specialist
CPL
TIPPERARY
QA Operations Specialist. Summary: Quality Support to Production activities including batch record review, in process checks, sampling, cleaning validation, equipment qualification, documentation review and audits to ensure batches are manufactured in compliance with regulatory requirements, company policy and procedures. Essential Duties and Responsibilities include, but are not limited to, the following: Support to batch manufacture including line sign-off prior to start of batch manufacture, performing in process checks during batch manufacture. Perform routine review of documentation such as Batch records, logbooks, forms, protocols, reports, COAs, etc. generated to support commercial and development batches for accuracy, completeness, and compliance to GMP and procedural requirements. Review of Standard Operation Procedures for manufacturing operations and cleaning. Participate in any investigation related to manufacturing. Prepare Standard Operating Procedures, investigations, reports and forms as required. Preparation, execution and coordination of Cleaning Development / Verification / Validation study protocols and reports; Preparation, execution and support of studies / risk assessments / investigations related to Cleaning;Perform swab sampling (bioburden and chemical. Review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Review and approval of calibration and PM activities (e.g. schedules) and Work orders. Perform internal / process audits. Monitoring of GMP compliance during production activities. Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences. Management of retain samples. Sampling and inspection activities. Issuance of documentation for production Batch Record, SOPs. Support training activities preparation / execution of on the job training. Support during regulatory/customer/corporate audits as required. Education & Experience: Adequate Experience on Pharmaceutical GMP environment accredited with HPRA and FDA. Min of 4 years relevant experience.
1477 days ago